(Bloomberg) -- Guardant Health Inc. shares rose after US regulators approved the company’s blood test for colorectal cancer as a primary screening tool at a time when the disease is rising at a worrying rate in younger Americans.
The US Food and Drug Administration cleared the test, known as Shield, in adults 45 and older who are at average risk for the disease, the Palo Alto, California-based company said in a statement. It’s the first blood test to be approved as a first-line screening option for colorectal cancer, the second-leading cause of cancer-related death in the US.
Guardant shares rose as much as 9% when US markets opened Monday.
A study of Guardant’s test in around 10,000 people found that 83% of people who had colorectal cancer detected in a colonoscopy screening received a positive result with its blood test.
Colorectal cancer rates have increased by 1% to 2% per year since the mid-1990s in people younger than 55, according to the American Cancer Society. More than 150,000 people are expected to be diagnosed with the cancers this year. Many people are not up-to-date with screening, which can prevent deaths.
About 20% of diagnoses in 2019 were in patients under age 55, nearly double the rate in 1995, according to the cancer society. Alarmed by the trend, the US Preventive Services Task Force recently lowered its recommended age to start colorectal cancer screening from 50 to 45.
--With assistance from Robert Langreth.
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